Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073209
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1991 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2012 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/14/2003 SUPPL-8 Labeling

Label is not available on this site.

09/18/2002 SUPPL-7 Labeling

Label is not available on this site.

08/28/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/15/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-1 Labeling

Label is not available on this site.

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; EQ 5MG ANHYDROUS;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET;ORAL Prescription No AB 071111 BARR
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG TABLET;ORAL Prescription No AB 073209 MYLAN

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